TARIS Bio posted on Wednesday positive data from its Phase 1b study of TAR-200 for the treatment of patients with muscle invasive bladder cancer (MIBC), neoadjuvant to radical cystectomy (RC).
Combined data from previous TAR-200 study hints a robust antitumor response on final histopathologic analysis after cystectomy, favorable tolerability profile, and no detectable systemic drug exposure or associated adverse events, the company said in the announcement.
According to Siamak Daneshmand, Director of Urologic Oncology at the USC Institute of Urology, and principal investigator of the study, the TAR-200-101 study has revealed exciting results in patients with muscle invasive bladder cancer. He said that such evidence of response, while early, may enable definitive treatment in patients currently unfit for curative intent therapy, including treatment with checkpoint inhibitors. Moreover, TAR-200 may also ultimately enable organ preservation strategies in lieu of radical cystectomy in patients who are unfit or unwilling to undergo bladder removal, Daneshmand said.
Tony Kingsley, President and CEO of TARIS, said that the data provide strong evidence of TAR-200’s anti-tumor activity and highlight the company’s product candidate’s potential to fundamentally change the management of the full spectrum of disease for patients with MIBC.
“The study results support our next stage of development that focuses first on the large portion of patients who do not receive potentially curative therapies. These patients typically have significant comorbidities and a poor overall performance status, rendering them unfit for current standards of care. With few options, these patients face rapid mortality from this unmanaged disease. We believe that TAR-200 is uniquely positioned to address this substantial and serious unmet need,” he said.